Session Title: Free Paper Session 14: AMD IV
Session Date/Time: Friday 08/09/2017 | 16:30-18:00
Paper Time: 17:36
Venue: Room 111
First Author: : G.Cheung SINGAPORE
Co Author(s): : T. Guerin P. Margaron
The EVEREST II study evaluated the efficacy and safety of ranibizumab 0.5 mg+verteporfin photodynamic therapy versus ranibizumab monotherapy in patients with symptomatic polypoidal choroidal vasculopathy (PCV). Here we report the predictors of best-corrected visual acuity (BCVA) gains from baseline at Month 12 in the EVEREST II study.
EVEREST II (NCT01846273), is an ongoing, 24-month, phase IV, randomized, double-masked, multicentre study that enrolled Asian patients with symptomatic macular PCV designed to compare the effects of combination therapy versus ranibizumab monotherapy with respect to change in BCVA from baseline and complete polyp regression at Month 12.
Overall, 322 patients with PCV were randomized 1:1 to receive ranibizumab+verteporfin photodynamic therapy or ranibizumab monotherapy. Predictors of BCVA change from baseline at Month 12 were estimated by a linear regression model using demographic, ocular, anatomic, and angiographic parameters either at baseline or Month 3. Each possible predictor was first assessed in a univariate model, and variables with a p-value <0.2 in the univariate model were then included in a backward elimination multiple regression analysis with a significance level of 0.05. The evaluated baseline factors included treatment regimen, age, and sex. Ocular parameters evaluated included BCVA, indocyanine green angiography features (polyp size, branched vascular network [BVN] size, presence of pulsation, and difference between mean time for polyp filling and BVN filling), optical coherence tomography features (central subfield thickness [CSFT], presence of subretinal fluid, presence of intraretinal fluid, presence of cysts, subfoveal choroidal thickness), and other lesion characteristics (choroidal neovascularization location, presence of massive submacular haemhorrage, presence of serosanguinous haemhorrage). Ocular features at baseline and Month 3 were evaluated in two separate models.
Analysis of the results at Month 12 showed that patients gained 8.3 letters and 5.1 letters in the combination and monotherapy arms, respectively (p=0.013). In the model evaluating baseline parameters, combination therapy, younger age, and lower BCVA were associated with higher BCVA gains from baseline at Month 12 (+4.02 letters, p=0.0009; −0.314 letter/year, p<0.0001; −0.210 letter/letter at baseline, p<0.0001, respectively). In the second model using parameters at Month 3, younger age, smaller polyps, lower CSFT, and higher BCVA were associated with higher BCVA gains (−0.244 letter/year, p=0.0012; −11.3 letters/mm2, p<0.0001; −0.015 letter/µm, p=0.0076; 0.104 letter/letter at Month 3, p=0.0243, respectively).
These findings confirm that combination therapy is superior to monotherapy for BCVA gains from baseline at to Month 12 in patients with PCV. They also suggest that younger patients may respond better to treatment. In addition, patients who have achieved thin retina and small polyps after the first three months of treatment predicted better BCVA gains.